The approval of the IgG4 monoclonal antibody is for adult patients suffering from the rare long-term autoimmune disorder and who are AchR or MuSK antibody positive
FDA approves UCB’s RYSTIGGO for the treatment of generalised myasthenia gravis. (Credit: UCB S.A., Belgium)
UCB has been granted approval for RYSTIGGO (rozanolixizumab-noli) by the US Food and Drug Administration (FDA) for the treatment of generalised myasthenia gravis (gMG) in adults.
The approval is for patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive, said the Belgian biopharmaceutical company.
Generalised myasthenia gravis is a rare long-term autoimmune disorder marked by its diversity in both phenotype and pathogenesis. It is distinguished by its unpredictable course and the harm it causes to the neuromuscular junction (NMJ), leading to impaired function.
According to UCB, RYSTIGGO injection, which is intended to be given subcutaneously, is a humanised IgG4 monoclonal antibody. The drug binds to the neonatal Fc receptor (FcRN), thereby lowering the circulating IgG.
RYSTIGGO is the only treatment in adults to have been approved by the FDA for both anti-AChR and anti-MuSK antibody-positive gMG, which are the two most prevailing subtypes of generalised myasthenia gravis.
UCB executive vice-president and chief medical officer Iris Loew-Friedrich said: “No two people living with gMG experience the disease in the same way, so we can’t take a ‘one size fits all’ approach to disease management.
“Disease management should be based on the clinical needs and preferences of the individual patient, and the aim of treatment is to help restore that patient’s ability to carry out activities of daily living. The approval of RYSTIGGO means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs.”
The FDA approval of RYSTIGGO has been driven by the positive findings of the Phase 3 MycarinG study. The drug candidate showed a statistically significant difference in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score change from baseline, which was the primary endpoint.
UCB expects to make RYSTIGGO commercially available in the US during the third quarter of this year.
The IgG4 monoclonal antibody is also being reviewed by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of Generalised myasthenia gravis in adults.